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Drugs in development · updated 30 October 2026

Intismeran autogene: clinical trials and development status

Other names and codes: mRNA-4157

FDA substance registryNot approved in the USNo EMA authorisationEstimated launch Dec 2030 – Oct 2031 (Phuturdex estimate)

As of 30 October 2026 Intismeran autogene is in 11 active clinical trials (recruiting or ongoing, phases I–III) for 6 diseases. The most advanced phase is III.

11Active trials
IIIMost advanced phase
6Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Intismeran autogene and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
MelanomaIII3NCT05933577
Non-small-cell lung carcinomaIII3NCT07513376
Bladder neoplasmII2NCT06833073
In situ carcinomaII1NCT06833073
Non-muscle invasive bladder neoplasmII1NCT06833073
Renal cell carcinomaII1NCT06307431

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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